Partell Specialty Pharmacy Recalls Testosterone Pellets Due to Sterility Concerns
Partell Specialty Pharmacy is recalling Testosterone 80 mg pellets in Nevada because they were sterilized using a non-approved method.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, FDA Class II recalls with potential for serious adverse health consequences (such as sterility failures in injectable drugs) are rated as Severe (4).
Plain-English summary
Partell Specialty Pharmacy is recalling Testosterone 80 mg pellets packaged in amber vials. The recall is due to a lack of assurance of sterility, as the firm used a non-approved method of sterilization for these drug products.
The affected products are prescription-only and were distributed in Nevada. Specific lot numbers and expiration dates are listed in the recall documentation. Consumers who have these products should stop using them and contact their healthcare provider or the pharmacy for instructions on disposal or replacement.
The recalled product
- Product
- Testosterone 80 mg pellet packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
- Manufacturer
- Partell Specialty Pharmacy
- Category
- Drug — Injectable Steroids
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- Lot#: 20171213@93
- BUD 06/11/2018
- 20171220@78
- BUD 06/18/2018
- 20171017@41
- BUD 04/15/2018
- 20171117@2
- BUD 05/16/2018
- 20171213@93
- BUD 06/11/2018.
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 49 recalled by Partell Specialty Pharmacy under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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